Florence Leclercq1, Pierre Robert2, Mariama Akodad3, Jean-Christophe Macia2, Thomas Gandet4, Delphine Delseny2, Marine Chettouh2, Laurent Schmutz5, Gabriel Robert6, Gilles Levy7, Frederic Targosz8, Eric Maupas9, Francois Roubille3, Gregory Marin10, Nicolas Nagot10, Bernard Albat4, Benoit Lattuca5, Guillaume Cayla5. 1. Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France. Electronic address: f-leclercq@chu-montpellier.fr. 2. Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France. 3. Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France. 4. Department of Cardiovascular Surgery, University Hospital of Montpellier, France. 5. Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France. 6. St. Pierre Clinic, Perpignan, France. 7. Millenaire Clinic, Montpellier, France. 8. Perpignan Hospital, Perpignan, France. 9. Franciscaines Clinic, Nimes, France. 10. Department of Medical Information, University Hospital of Montpellier, Montpellier, France.
Abstract
OBJECTIVES: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BACKGROUND: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. METHODS: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. RESULTS:Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. CONCLUSIONS: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).
RCT Entities:
OBJECTIVES: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BACKGROUND: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. METHODS:DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. RESULTS: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. CONCLUSIONS: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).
Authors: Florence Leclercq; Pierre Alain Meunier; Thomas Gandet; Jean-Christophe Macia; Delphine Delseny; Philippe Gaudard; Marc Mourad; Laurent Schmutz; Pierre Robert; François Roubille; Guillaume Cayla; Mariama Akodad Journal: J Clin Med Date: 2022-05-16 Impact factor: 4.964